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Completed

NCT Number: NCT04315376

Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese Adults

Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. The apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) protein is part of NLRP3 inflammasome, a complex related to inflammation and metabolic alterations.

Purpose: The aim of this study was to evaluate the effect of physical exercise program on ASC gene expression and inflammatory markers in obese adults.

Methods: 37 obese individuals were randomized to exercise-diet group or diet-group during a 4-month follow-up period. The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350). ASC messenger ribonucleic acid (mRNA) expression was performed by real-time polymerase chain reaction (PCR) using Taqman probes and by the 2-ΔΔcq quantification method. Cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.

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Key information

Conditions

Inflammatory Response Abdominal Obesity Behavior Behavior, Animal Body Weight Diet Habit Exercise Feeding Behavior Inflammation Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erika Martínez-López

Guadalajara, Jalisco, 44340, Mexico

About this study

A randomized clinical trial was conducted in the Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology in Medicine, Health Sciences Center, at the University of Guadalajara, Guadalajara, Jalisco, Mexico, from February of 2018 to February of 2019. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 13 participants in each study group was required. However, 37 obese individuals who met the selection criteria were randomized in exercise-diet group or diet-group. Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes. The participants in the exercise-diet group were cited in the Respiratory Unit of the University of Guadalajara with the indication of not consuming caffeine, tobacco or energy drinks 24 hours before the test, and not having eaten food at least two hours before the Astrand-rhyming Test. This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (registry number CUCS/CINV/0476/18). The procedures were in accordance with this institution's guidelines and all the participants signed a written consent-informed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI greater than 30 kg/m^2
  • Sedentary individuals
  • Both genres
  • Waist circumference greater than 80 centimeters in women and greater than 90 centimeters in men

Exclusion criteria

  • Pregnant or breastfeeding women
  • Diagnosis of any metabolic disease or cancer
  • Alcohol or tobacco consumption
  • Muscle or joint injury

Treatment and study plan

Exercise-Diet Intervention

Behavioral

The participants who performed exercise-diet intervention performed an Astrand-rhyming test before and after the exercise program intervention. Participants followed a progressive exercise-program during four months according to initial physical fitness. The main exercises consisted of improving aerobic, speed and resistance performance. During all single sessions, breathlessness and fatigue were measured using 0 to10 Borg scale. A personal trainer certified by American College of Sports Medicine (ACSM) supervised three sessions per week, the other two unsupervised training days the subjects were given the detailed training program to do in house/park. And also, this group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.

diet intervention

Behavioral

This group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.

Primary outcomes

  1. Change in ASC mRNA Expression

    Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.

    The polymorphonuclear cells were separated using Dextran treatment from peripheral blood samples. Subsequently, TRIzol® reagent was using according to the manufacturer´s instructions. The complementary DNA (cDNA) synthesis was performed according to standard techniques.

    Quantitative real-time PCR was performed using TaqMan® probes in Light Cycler 96 equipment considering standards PCR conditions to analyze ASC mRNA relative expression by 2-ΔΔcq method. The amplification reactions were performed in duplicate using β-Actin gene as constitutive gene to normalized the samples.

  2. Change in Pro-inflammatory and Anti-inflammatory Cytokines

    Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.

    The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.

  3. Change in Astrand-rhyming Submaximal Test

    Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month.

    The Astrand-rhyming submaximal test was performed as described by Astrand.

Secondary outcomes

  1. Changes in Height

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month. 1st month, 2nd month, 3th month and the 4th month.

    Height in meters using a stadiometer.

  2. Changes in Weight

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    The weight was measured in kilograms on InBody 370.

  3. Changes in Body Mass Index (BMI)

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    Weight and height were be combined to report BMI in kg/m^2

  4. Changes in Waist Circumference

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    Waist circumference was measured at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.

  5. Changes in Fat Mass

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    The Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.

  6. Changes in Musculoskeletal Mass

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    The musculoskeletal mass was measured in kilograms by electrical bioimpedance on InBody 370.

  7. Changes in Serum Glucose

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  8. Changes in Serum Insulin

    Time frame: At the baseline (0 Month), 3th month and the 4th month.

    Were determined through Insulin Model ELISA kit following the supplier's instructions.

  9. Changes in homeostatic model assessment - insulin resistance (HOMA-IR)

    Time frame: At the baseline (0 Month), 3th month and the 4th month.

    Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.

  10. Changes in Total Cholesterol

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  11. Changes in High-density lipoprotein (c-HDL)

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  12. Changes in Atherogenic Index

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    Serum total cholesterol and c-HDL were be combined to report atherogenic index, calculated through formula [Total cholesterol (mg/dL) / HDL-c (mg/dL)].

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults

Acronym: INDIEX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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